Device product
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Z-2532-2024
Product summary
- Firm
- Artivion, Inc
- Event
- Event 94909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 arteries, 1 patch
- Official record key
device-enforcement:Z-2532-2024
Official wording
Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Code information: (1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.
Distribution pattern: US Nationwide distribution in the states of CA, DC, FL, and NY.
Derived failure modes
-
Unknown
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.